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Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
5-fluorouracil
Mitomycin C
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Trabeculectomy, 5-fluorouracil, Mitomycin C

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Only patients deemed successful as 36 months will be included. These patients will have participated in the randomized prospective study trial comparing intraoperative 5-FU and mitomycin C in primary trabeculectomy. Exclusion Criteria: Only patients deemed successful as 36 months will be included. These patients will have participated in the randomized prospective study trial comparing intraoperative 5-FU and mitomycin C in primary trabeculectomy.

Sites / Locations

  • University Hospital and Outpatient Center
  • IU Eye at Carmel

Outcomes

Primary Outcome Measures

Pressure Control

Secondary Outcome Measures

Mitomycin Complications

Full Information

First Posted
June 28, 2006
Last Updated
December 21, 2007
Sponsor
Indiana University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00346489
Brief Title
Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C
Official Title
Intermediate Term Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin c in Trabeculectomy Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Indiana University School of Medicine

4. Oversight

5. Study Description

Brief Summary
A clinical trial to establish the long term response of using intraoperative 5-fluorouracil (5-FU) versus mitomycin C (MMC) in trabeculectomy glaucoma surgery. Antiproliferative agents such as 5-fluorouracil and Mitomycin C have been used extensively in trabeculectomy surgery to improve the success of the surgery and prevent further visual loss and blindness in glaucoma patients.
Detailed Description
Glaucoma is a life-long progressive disease, and patients are living longer. Therefore, a long term full evaluation of the efficacy of intraoperative 5-FU and MMC needs to be performed to assess the true efficacy of MMC compared to 5-FU. We, therefore propose, a long-term prospective study of patients previously enrolled in the prospective study involving the evaluation of single intraoperative application of mitomycin C versus 5-fluorouracil in low to moderate risk glaucoma patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Trabeculectomy, 5-fluorouracil, Mitomycin C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
70 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Type
Drug
Intervention Name(s)
Mitomycin C
Primary Outcome Measure Information:
Title
Pressure Control
Secondary Outcome Measure Information:
Title
Mitomycin Complications

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Only patients deemed successful as 36 months will be included. These patients will have participated in the randomized prospective study trial comparing intraoperative 5-FU and mitomycin C in primary trabeculectomy. Exclusion Criteria: Only patients deemed successful as 36 months will be included. These patients will have participated in the randomized prospective study trial comparing intraoperative 5-FU and mitomycin C in primary trabeculectomy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis B Cantor, MD
Organizational Affiliation
IUPUI/Clarian
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital and Outpatient Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
IU Eye at Carmel
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1565457
Citation
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Results Reference
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Citation
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PubMed Identifier
2023752
Citation
Palmer SS. Mitomycin as adjunct chemotherapy with trabeculectomy. Ophthalmology. 1991 Mar;98(3):317-21. doi: 10.1016/s0161-6420(91)32293-0.
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1882947
Citation
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PubMed Identifier
2688428
Citation
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Results Reference
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Citation
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Citation
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Citation
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Citation
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Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C

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